Trials / Completed
CompletedNCT03336450
Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Pediatric Patients With Status Epilepticus (Convulsive) in the Community Setting
A Phase 3, Multicenter, Open-label Extension Study of Buccally Administered MHOS/SHP615 in Pediatric Patients With Status Epilepticus (Convulsive) in Community Settings
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 6 Months – 216 Months
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if the investigational treatment, MHOS/SHP615, is safe and effective in children with status epilepticus (SE) (convulsive) in the community setting. This study is open-label extension for patients who completed the SHP615-301 study and who tolerated and responded to MHOS/SHP615 treatment in the hospital setting.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHP615 | SHP615 oromucosal solution will be administered as a single age-specific dose (2.5, 5, 7.5 and 10 mg). |
| DRUG | MHOS/SHP615 | MHOS/SHP615 |
Timeline
- Start date
- 2018-04-23
- Primary completion
- 2020-10-13
- Completion
- 2020-10-13
- First posted
- 2017-11-08
- Last updated
- 2021-09-14
- Results posted
- 2021-09-14
Locations
23 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT03336450. Inclusion in this directory is not an endorsement.